BHV-7000 Open-Label Extension Bipolar Mania Study

December 13, 2025 updated by: Biohaven Therapeutics Ltd.

A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Bipolar I Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pillar Clinical Research, LLC
      • Little Rock, Arkansas, United States, 72211
        • WIRG
      • Rogers, Arkansas, United States, 72758
        • WRN
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Bellflower, California, United States, 90706
        • CIT LA
      • Culver City, California, United States, 90230
        • Proscience Research Group
      • Garden Grove, California, United States, 92845
        • CenExel CNS
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Riverside, California, United States, 92506
        • CIT IE
      • Torrance, California, United States, 90504
        • CenExel CNS
    • Florida
      • Hollywood, Florida, United States, 33021
        • Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
      • Hollywood, Florida, United States, 33024
        • Cenexel - RCA
      • Miami, Florida, United States, 33126
        • LCC Medical Research Inst
      • Miami Lakes, Florida, United States, 33016
        • Floridian Neuroscience Institute
      • Miami Lakes, Florida, United States, 33016
        • Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
      • West Palm Beach, Florida, United States, 33407
        • Neuroscience Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch, LLC
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute
      • Chicago, Illinois, United States, 60641
        • Pillar Clinical Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Clinical Research
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Arch Clinical Trials
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute
    • New York
      • Staten Island, New York, United States, 10329
        • RBA
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
      • North Canton, Ohio, United States, 44720
        • NBCR
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research, LLC
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Subjects must have successfully completed the parent study, BHV7000-204.
  2. WOCBP must have a negative urine pregnancy test at Baseline visit.
  3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.

Key Exclusion Criteria:

  1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
  2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
  3. Investigator deems subject at imminent risk of danger to others or themself.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHV-7000
Drug: BHV-7000
BHV-7000 75 mg taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
Time Frame: Up to 52 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).
Up to 52 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Up to 52 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Up to 52 weeks
Number of Participants With Vital Sign Abnormalities
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time Frame: Up to 52 weeks
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV7000-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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